Zdrowie i gospodarka · 07/04/2014

FDA Seeks Public Comment on Proposed Guidance for Updating Labeling in Antibacterial Drug Products and Antimicrobial Testing Devices

The Food and Drug Administration (FDA) is seeking public comment on a proposed collection of information related to updating labeling for susceptibility test information in systemic antibacterial drug products and antimicrobial susceptibility testing devices. The proposed guidance aims to describe procedures for updating labeling information, including susceptibility test interpretive criteria, methods, and quality control parameters.